Stryker
recalled its Rejuvenate and ABG II modular hip implant systems on July 6, 2012,
after the implants showed signs of corroding and fretting – wear that occurs
from the constant rubbing together of two pieces, causing bits of metal to
crack or flake. Stryker aggressively marketed these products as safe and
effective and claimed its patented metal mixture of titanium and cobalt chrome
resisted corroding and fretting. Instead, after the devices were already
implanted, the implant released bits of metal debris causing premature failure,
pain, and tissue and bone death.
Metallosis, an injury
attributed to metal-on-metal hips, is an adverse tissue reaction to heavy
metals in the body. It can cause pain, limited mobility, failure of the hip
joint, pseudo-tumors, dissolution of the bone, DNA changes and chromosomal
aberrations. Typically, hip implants are expected to last 15 to 20 years. In
some cases, the Stryker Rejuvenate hips are failing in less than five years.
Approximately 20,000
Stryker Rejuvenate and ABG II devices were implanted between 2009 and 2012.
Before the recall, Stryker acknowledged that it was aware of the problems by
sending an Urgent Field Safety notice to doctors in April 2012. Stryker, based in Kalamazoo, Michigan, is a
subsidiary of Howmedica Osteonics Corporation of Mahwah, New Jersey.
The Stryker Rejuvenate hip implant is
functionally different from other hip replacement devices that are being
litigated because it is not a metal-on-metal hip replacement device. Instead,
the Rejuvenate hip replacement device, which uses a ceramic component, was
meant as an alternative to the metal-on-metal devices. Like the DePuy ASR, it
was marketed to younger patients as a modular hip replacement, meaning the
components were custom-made to fit patients better. This was supposed to result
in longer-lasting hip replacement devices that offered a better range of
motion.
Some patients reportedly developed
metallosis from the Stryker Rejuvenate hip. It was initially believed that such a condition was not possible because the
Stryker Rejuvenate does not have a metal-on-metal ball and socket design, which
is basically what the DePuy ASR and Pinnacle models are. However, it does have a metal neck piece that can, under some conditions, rub against a metal
stem, causing metallic debris to come loose.
Stryker has responded to concerns about
the Rejuvenate failure rate by alleging patients did not properly undergo
rehabilitation following surgery, or by blaming doctors' implantation
techniques. In a Product Correction Bulletin posted on April 4, 2012,
Stryker representatives noted, "Factors such as diabetes and infection may
play a role in potential corrosion of an implant as these conditions may affect
the pH of the tissue surrounding the implant." To this writer, this claim
is preposterous. How could elevated
cobalt levels be attributed to diabetes, much less infection? I doubt this ‘blame
the victim’ defense will hold up to a jury.
Lawsuits have already been
filed in the United States over these devices. Many have been consolidated in
the New Jersey Superior Court, Bergen County, Case 296. A case
management conference has been scheduled regarding the Stryker
Rejuvenate Hip Stem and the ABG II Modular Hip Stem litigation on March 19, 2013. It is not certain yet if other cases filed nationwide will be consolidated by the JPML into an MDL.
The attorneys at Pittman,
Dutton & Hellums, P.C., are investigating claims against Stryker for the Rejuvenate and ABG II hips. If you or a loved one have been implanted with a Stryker
Rejuvenate Hip or the ABG II Modular Hip, contact Booth Samuels at booths@pittmandutton.com
or toll free at 1-866-515-8880.
